Questionnaires & Structured Data Capture (SDC) · Original Structured Data Capture (SDC) • U.S. Office of the National Coordinator for Healthcare (ONC) initiated project • Parallel

HL7®, FHIR® and the flame Design mark are the registered trademarks of Health Level Seven International and are used with permission.

Amsterdam, 14-16 November | @HL7 @FirelyTeam | #fhirdevdays18 | www.fhirdevdays.com

Questionnaires & Structured Data Capture (SDC)

Lloyd McKenzie, Gevity Consulting

Who am I?

• Name: Lloyd McKenzie• Company: Gevity• Background:

• One of FHIR’s 3 initial editors• Co-chair MnM, FMG & FHIR Infrastructure• Technical lead for ONC’s FHIR SDC project

• Same role for NLM-funded internationalization/update project• Heavily involved in HL7 and healthcare exchange for last 19 years

• v2, v3, CDA, etc.• [email protected]

2

Objectives

• What are FHIR Questionnaires for?• FHIR vs. SDC IG• What does SDC provide?

3

What are Questionnaires for?

4

Questionnaire

• Used to represent forms/surveys/case report forms/etc.• Can capture any sort of information

• clinical, administrative, financial, research, public health, …

• Hierarchical collections of questions• May include ‘groups’ and instructions/guidance• Control over allowed answer optionality, repetition, data type, options• Some elements might be conditional

• e.g. “if question 2=female, then display question 5”

5

QuestionnaireResponse

• A single (fully or partially) completed form• Ties to exactly one Questionnaire• Lets you see and compare “raw” data• Can’t be used for direct query based on answer values

• Too hard to manage context implicit in instructions/other questions

• Data is not comparable if captured based on different Questionnaires

Example

• Questionnaire question:• “When were you born?” Answer: string• “How old are you (in years)?” Answer: integer/decimal• “How old are you?” Answer:

(a) 0-18; (b) 19-30; (c) 31-50; (d) 51+• “What was your birth year?” Answer: integer

“What was your birth month?” Answer: integer• Etc.

• Patient question:• Patient.birthDate? Answer: date (yyyy, yyyy-mm, yyyy-mm-dd)

Questionnaire usage

• Questionnaire• Raw data capture or tight control over display• Retain “source of truth” for data• Generic mechanism for non-FHIR aware systems

• Other resources• Search• Decision support• Consistency of representation independent of source

• In many cases, you may need both

What is SDC?

9

Original Structured Data Capture (SDC)

• U.S. Office of the National Coordinator for Healthcare (ONC) initiated project

• Parallel efforts in IHE (custom schema) and FHIR• FHIR effort had 2 focuses

• Standardizing the sharing of data elements (IS 11179-aligned)• Supporting standardization of Questionnaire usage and enabling pre-

population and auto-population

• Separate FHIR IGs created for each

10

SDC Phase II

• Funded by US National Library of Medicine• Scope:

• Update the SDC implementation guide to align with R4• Make the IG international in scope• Add new rendering/control capabilities• Figure out a population/extraction mechanism that’s workable

• Targeting Standard for Trial Use (STU) ballot opening in April

Why SDC?

• Base FHIR resources • almost everything optional• Focus is “what do most systems do?”

• Most systems includes lots of very limited systems• Provides base level interoperability across all systems

• SDC implementation guide• Sets “higher” expectations for systems dealing with more sophisticated forms• Provides confidence that forms will be rendered and will capture data as

intended

SDC defines 6 things

• Standard workflow models and roles for managing, discovering and completing forms

• Sophisticated rendering capabilities• Sophisticated behavior/flow control capabilities• Pre-populate/auto-populate forms• Extract resources from forms• Adaptive forms

• Systems choose what to adapt

Capabilities defined by

• Describing conformance expectations around existing extensions• Defining new extensions• Documenting (and providing examples) showing how the capabilities

can be used for real-world healthcare scenarios

Where can SDC be useful?

• Submitting forms for clinical research• Submitting public health forms• Submitting and processing electronic insurance claims (pre-

authorizations, special authorizations, etc.)• Any area where questionnaires/forms are a standard mechanism for

data collection

15

Argonaut Questionnaire

• What questionnaire capabilities should U.S. EHRs support?• Much simpler than SDC – but aligned• Expectation is that more complex (SDC) forms will be handled

through SMART on FHIR apps

SDC capabilities

17

SDC Workflow

• Who are the participants?• What do they do?• What’s the base metadata

for searching?

Form rendering

• Embedded HTML• Table rendering• Sliders• Item-level labels

• Form translation• Question grids• Form translation

Complex behavior

• Calculated fields (e.g. scores)• Calculated decision points

• E.g. Display question 5 IIF cumulative score <0.3

• Calculated default values• Multi-column drop-downs

Population operations

• $populate• Get back a QuestionnaireResponse

• $populatehtml• Get back HTML with active submit button

• $populatelink• Get back URL to site displaying interactive (and partially populated) form

21

Form population

• Don’t make user fill in what’s already in the EHR/other systems• Contents of forms must be “computably” derivable from standardized

data• SDC Phase II focus is FHIR-based data, not CDA

Multiple population levels

• Full population: Answer automatically filled in• E.g. Patient’s name, gender, address

• Choice selection: Possible choices for answer• E.g. “List all potentially relevant concomitant medications”

• Answer context: Information to help user formulate an answer• E.g. “Has the patient had similar procedures in the past?”

3 data representation approaches

• Observation-based• Question/group tied to specific question code (e.g. LOINC)

• FHIRPath based• Pass in context (Patient, Encounter, other?)• Perform queries to set context for Questionnaire/group• FHIRPath to calculate variables• Question/group context tied to specific FHIRPath

• StructureMap• Formal mapping from QuestionnaireResponse to completed Questionnaire

Extraction

• User has filled in a Questionnaire• How do I make that data available to:

• Decision support• Available using standard profiles (Argonaut, Australian core, etc.)• Discoverable by queries?

• Need to move data into “regular” resources• Observation, Encounter, MedicationStatement, etc.

• $extract operation

Extraction approach

• Leverage same technologies as population• Observation• StructureDefinition

• Also support “Definition”-based• Link questions/groups to particular profiles and profile elements

Adaptive forms

• Hide the complexity of the questionnaire logic• Hit the server with “answers so far”• Server returns an updated questionnaire adding one more question• Supported by Argonaut Questionnaire

• $nextQuestion operation

Current state

• Hope to go to ballot in May 2019• Publish as STU in late 2019• Actively testing at connectathon• SMART on FHIR app ~50% done• Still work to do defining examples, determining conformance

requirements

To participate in SDC

• Weekly calls, 5 Eastern• Details (and minutes) available from the FHIR wiki:

• http://wiki.hl7.org/index.php?title=FHIR_Structured_Data_Capture

Questions / Discussion?

• http://build.fhir.org/ig/HL7/sdc• https://github.com/HL7/sdc

• https://chat.fhir.org/#narrow/stream/102-questionnaire

• [email protected]

30